1. to compare the extent of reversal of left ventricular remodelling at 3 months and 1 year after a TAVI procedure between patients with a TAVI-induced LBBB and patients without a LBBB; 2. comparison of strain patterns in TAVI-induced LBBB (as being…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To compare the extent of reversal of left ventricular remodelling at 3
months and 1 year after a TAVI procedure between patients with a TAVI-induced
LBBB and TAVI patients without LBBB. Left ventricular remodelling will be
defined using echocardiographic parameters (left ventricular endsystolic
diameter, left ventricular ejection fraction, left ventricular mass, global
longitudinal and circumferential 2D-strain).
2. To evaluate and compare the immediate and long-term effects of a
TAVI-induced and non-TAVI-induced LBBB on the ECG, regional and global
2D-strain profile of the left ventricle in a circumferential and longitudinal
direction. 2D-Strain will be measured by post-processing of B-mode
echocardiographic images (speckle tracking).
Secondary outcome
1. To compare the TAVI-induced LBBB ECG profile and 2D-strain pattern to that
of patients with spontaneous LBBB in order to discriminate a proximal from
distal LBBB.
2. To correlate the ECG profile and 2D-strain of TAVI-induced LBBB with that of
CRT patients with LBBB and indicate whether a dyssynchrony caused by
TAVI-induced LBBB is likely to respond to CRT.
3. To evaluate the feasibility of 3D-TOE in guiding placement of the aortic
tissue valve during TAVI procedure
Background summary
The introduction of the transcatheter aortic valve implantation (TAVI) has
proven to be a valuable alternative to surgical valve replacement in the older,
co-morbid patient with a high operative mortality risk. However, as a
consequence of the properties of the self-expanding stent, there is a high
incidence of newly-acquired left bundle branch block (LBBB) after TAVI
presumably caused by localised pressure of the stent on the ventricular septum.
The clinical consequence of this new-onset LBBB is not known , however in
general cardiology it is well appreciated that LBBB is an independent predictor
of cardiovascular disease and LBBB has been shown to induce dilatation of the
LV cavity and hypertrophy.
Secondly, the TAVI-induced LBBB is a proximal block of which the onset is
exactly known. These unique characteristics offer possibilities to study the
changes of left ventricular mechanical properties caused by LBBB in time.
Although extensively studied in animals, so far it has not been possible to do
so in patients with LBBB simply because the onset of the bundle branch block is
unknown. This knowledge can contribute to better understanding of LBBB in
general and the application of cardiac resynchronization therapy (CRT).
Thirdly, there is evidence that the depth of prosthesis implantation is a risk
factor for the development of TAVI-induced LBBB. Three-dimensional
transoesophagal echocardiography could be of additional value in defining
correct size and guiding placement of the aortic tissue valve.
Study objective
1. to compare the extent of reversal of left ventricular remodelling at 3
months and 1 year after a TAVI procedure between patients with a TAVI-induced
LBBB and patients without a LBBB; 2. comparison of strain patterns in
TAVI-induced LBBB (as being a clear example of proximal LBBB) with that in a
group of CRT patients.
Study design
a single-centre, prospective, nonrandomized study.
Study burden and risks
both the TAVI intervention and the clinical and echocardiographic assessment
are part of routine clinical practice concerning the percutaneous aortic valve
replacement. The transesophagal echocardiography is also a standard procedure
during TAVI intervention. 3-Dimensional images are additionally recorded
without additional burden for the patient. Only the echocardiographic
examination performed within 1 week after the TAVI procedure is supplemental.
However, this examination will be performed during hospital stay and is in
general not considered as a burden by patients.
Postbus 1350
5602 ZA Eindhoven
NL
Postbus 1350
5602 ZA Eindhoven
NL
Listed location countries
Age
Inclusion criteria
patients planned/accepted for transcatheter aortic valve implantation
Exclusion criteria
inability to give informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL33070.060.10 |